Clinical Trial: Observational Plan to Obtain Clinical Experience and Follow up Data on the Use of the ProxiFuse Hammer Toe Device

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Observational Plan Designed to Obtain Clinical Experience and Follow up Data on the Use of the ProxiFuse Hammer Toe Device for the Fixation of Osteotomies and Reconstruction of the Lesser Toes Followi

Brief Summary: This is a multi-center, non-randomized, observational study to further evaluate the effectiveness and safety of the Proxifuse Hammer Toe Device when utilized for bone fixation. Approximately 4 US sites will participate. The primary endpoint will evaluate the 6 month post surgery change from baseline in the PROMIS Pain Interference computerized adaptive test (CAT) score.

Detailed Summary:

This is an observational plan designed to obtain clinical experience and follow up data on the use of the ProxiFuse Hammer Toe Device for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Collection of data on patients treated with the FDA 510k approved ProxiFuse Hammer Toe Device will assist Cartiva in further evaluation of the effectiveness and safety of the ProxiFuse Hammer Toe Device when utilized for bone fixation per the specified indications. The ProxiFuse Hammer Toe Device is currently approved for commercial distribution and use in the country in which this protocol is being administered (FDA 510k approval K142490). . Given that the product is approved for distribution and use, the product is being used within its approved indication for use, and the data being collected is not burdensome or outside the standard of care, it is determined that no additional regulatory requirements are applicable to this data collection.

The ProxiFuse Hammer Toe Device consists of three components: the implant, deployment instrumentation, and bone awl. The implant is comprised of 2-0 suture, two Nitinol anchors with PEEK Inserts, and a PEEK Stabilizing Body. The device is delivered through a specifically designed instrument. The method of delivery allows for a shifting of the PEEK Body which limits the amount of traction required to place the middle phalanx over the device. The suture utilized in the device serves to shift the PEEK Body and to apply tension between the Nitinol anchors which in turn stabilizes the proximal interphalangeal joint.

In accordance with guidelines as outlined in ISO 14155, ICH GCP, and 21 CFR Part 50, each patient must grant documented informed consent and authorization
Sponsor: Cartiva, Inc.

Current Primary Outcome: PROMIS Pain Interference computerized adaptive test (CAT) score [ Time Frame: Change from baseline at 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • PROMIS Pain Interference CAT scores [ Time Frame: Change from baseline at 2 weeks; 6 weeks and 3 months after surgery ]
  • PROMIS Physical Functioning CAT scores [ Time Frame: Change from baseline at 2 weeks; 6 weeks; 3 months and 6 months after surgery ]
  • Time to return to normal shoe wear [ Time Frame: Time recorded. Subjects will be queried at 2 weeks; 6 weeks; 3 months and 6 months and an actual date recorded. The number of days following surgery will be recorded for analysis ]
    Normal shoe wear defined as being anything other than a post surgical sandal or boot
  • Postoperative Adverse Events that require a return to the operating room [ Time Frame: From Operative time through 6 months ]


Original Secondary Outcome: Same as current

Information By: Cartiva, Inc.

Dates:
Date Received: May 15, 2015
Date Started: June 2015
Date Completion:
Last Updated: March 20, 2017
Last Verified: July 2016